How do you set a launch price that supports both reimbursement and profitability?
We support Pricing and Reimbursement across the lifecycle: launch price, early benefit assessment under Sec. 35a and reimbursement price negotiation under Sec. 130b SGB V. The lever is the launch sequence: a low, referencing-relevant price accepted early can affect achievable prices in other markets whose reference basket includes this country.
Overview
Which rules determine price and reimbursement in the German and European market?
Support across the full reimbursement lifecycle · AMNOG (§ 35a, § 130b SGB V), AM-NutzenV, EU-HTA (EU 2021/2282)
Last updated: October 9, 2026
Pricing and reimbursement in Germany follow different rules for medicinal products and medical devices. For medicinal products subject to the early benefit assessment, the benefit assessment under § 35a SGB V is, as a rule, followed by the reimbursement amount agreement under § 130b SGB V. For medical devices, other remuneration mechanisms apply, in particular sector-specific ones.
- The added benefit determines the room for negotiation: the early benefit assessment under § 35a SGB V compares the new medicinal product against the appropriate comparator therapy; the extent of the recognized added benefit is the central criterion for the reimbursement amount.
- The reimbursement amount is negotiated, not dictated: under § 130b SGB V, the manufacturer and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) agree the reimbursement amount on the basis of the assessment result; without a recognized added benefit, the amount is anchored to the costs of the comparator therapy.
- The EU HTA Regulation (EU) 2021/2282 shifts part of the clinical assessment to the European level. Since 12 January 2025, the Joint Clinical Assessment has applied to the covered new oncology products and advanced therapy medicinal products (ATMPs). At the time of the EMA marketing authorization submission, information for determining the assessment scope must first be sent to the HTA secretariat. The full JCA dossier is then submitted upon request within the applicable deadlines.
- For medical devices, reimbursement pathways other than the AMNOG procedure apply. In the inpatient setting, remuneration is generally provided through the hospital remuneration system. For new diagnostic and treatment methods, supplementary NUB charges can be agreed under the conditions of § 6(2) KHEntgG. Where the statutory requirements are met, a method assessment under § 137h SGB V must also be carried out.
- External reference pricing couples markets: many countries take into account the prices of selected reference countries when setting their national prices. A low price accepted early that is relevant for referencing can therefore also affect price setting in other markets, provided that this price is taken into account under the respective national rules.
Services
How we support you
Launch Price & Pricing Strategy
Deriving a defensible launch price from the added-benefit hypothesis, the cost of the appropriate comparator therapy and willingness to pay. The output is a documented price corridor with a rationale for each scenario.
Launch Sequencing & ERP Management
Ordering market entries along reference-pricing logic so that the possible effects of a low, referencing-relevant price on other target markets are taken into account before the price negotiations. The launch map is prioritized and shows the reference-country dependencies.
Performance- & Volume-Based Reimbursement Agreements
Designing performance- and volume-based contract models (pay-for-performance, volume tiers, annuities) where the standard reimbursement amount does not reflect the value proposition. The output is a negotiation-ready contract draft.
MedTech & IVD Reimbursement
Clarifying the reimbursement pathway for medical devices and diagnostics via the hospital remuneration system, NUB charges under § 6(2) KHEntgG, the method assessment under § 137h SGB V, and the outpatient remuneration routes. The reimbursement pathway is secured per product.
EU HTA Preparation (Joint Clinical Assessment)
Building the clinical evidence package for the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282, including preparing the information for determining the assessment scope at the EMA submission and then preparing the JCA dossier in line with the specified PICO requirements and submission deadlines.
How we work together
What it comes down to
The achievable price is decided before the first negotiation meeting. Several pieces have to fit together, and in the right order: the added-benefit hypothesis determines which reimbursement amount is even negotiable under § 130b SGB V.
The benefit dossier for the early benefit assessment under § 35a SGB V has to substantiate this hypothesis against the appropriate comparator therapy with robust evidence meeting the requirements of the AM-NutzenV.
And the launch sequence helps determine whether a low, referencing-relevant price can influence pricing in other markets through external reference pricing, provided it is taken into account there under the national rules. That is why it belongs at the start of planning.
For medical devices and diagnostics, a different reimbursement logic applies than for medicinal products. Inpatient remuneration is generally provided through the hospital remuneration system. For new diagnostic and treatment methods, supplementary NUB charges under § 6(2) KHEntgG may come into consideration. Where the statutory requirements are met, a method assessment under § 137h SGB V is also required.
The GKV-Beitragssatzstabilisierungsgesetz has extended the scope of § 137h SGB V. In the future, the information submission generally concerns new diagnostic and treatment methods that are not based decisively on the administration of a medicinal product alone and for which a NUB request is made for the first time. The extended procedure applies only once the G-BA's amended Rules of Procedure take effect. Under the procedural resolution of 17 September 2026, this was not expected before 31 October 2026. Until then, the previous procedural requirements continue to apply.
For findings of potential in the extended assessment procedure, § 137h(4) SGB V provides for a restriction of NUB remuneration. Such charges can be agreed for university hospitals and for other hospitals, provided they meet the quality requirements set by the G-BA. The rule must be distinguished from previous procedural practice and must not be transferred across the board to findings of potential under the procedure applied so far.
For new oncology products and advanced therapy medicinal products, the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282 has applied since 12 January 2025: the clinical assessment shifts partly to the EU level, while pricing remains national.
Our work starts with the international launch sequence. It should be set early so that pricing decisions relevant for referencing and their possible effects on other target markets can be taken into account before the respective price negotiations.
Our approach
Our approach
Step
Result
Value & price hypothesis
Documented price corridor with an added-benefit hypothesis against the appropriate comparator therapy and willingness-to-pay assumptions.
Define the launch sequence
Prioritized launch map that accounts for the reference-pricing dependencies between the target markets.
Prepare the benefit dossier
Dossier for the early benefit assessment under § 35a SGB V with an evidence-backed chain against the defined comparator therapy.
Negotiate the reimbursement amount
Prepared negotiation position and an agreed reimbursement amount under § 130b SGB V.
Design the contract model
Where appropriate, a performance- or volume-based reimbursement agreement as an alternative to the plain reimbursement amount.
Safeguard the price across markets
Aligned pricing strategy that takes into account the possible effects of external reference pricing on other markets.
Common pitfalls
Where projects commonly fail
The launch price is set too high or without reference-country logic.
A low price in an early-entered market that is relevant for international price referencing can negatively affect the achievable prices in other countries, provided they take that price into account in their national reference pricing.
The appropriate comparator therapy is not clarified up front.
The early benefit assessment under § 35a SGB V measures the added benefit against this comparator therapy; a wrong assumption here leaves the entire dossier, and the price hypothesis derived from it, open to challenge.
The benefit dossier is written from a marketing rather than an assessor perspective.
Only evidence that withstands the methodological requirements of the AM-NutzenV is recognized; value arguments without robust comparative data produce no recognized added-benefit category and therefore no negotiation leverage under § 130b SGB V.
Medical devices do not go through the AMNOG procedure.
Their reimbursement depends in particular on the care sector and the applicable remuneration system. In the inpatient setting, supplementary NUB charges under § 6(2) KHEntgG and a method assessment under § 137h SGB V may become relevant. Failing to take these procedures and their requirements into account early risks delays in market access to reimbursable care.
The EU HTA evidence package is set up too late.
For medicinal products covered by the Joint Clinical Assessment, information for determining the assessment scope must already be provided at the EMA submission. The full JCA dossier must be submitted upon subsequent request within the applicable deadlines. A purely national dossier strategy does not adequately account for these additional requirements.
Market Access, RWE & Reimbursement
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Fünftes Buch Sozialgesetzbuch (SGB V), German Social Code, Book V, primary text, § 35a, § 130b, § 137h
- Arzneimittel-Nutzenbewertungsverordnung (AM-NutzenV), Medicinal Products Benefit Assessment Ordinance, primary text
- Regulation (EU) 2021/2282 on health technology assessment (EU HTA Regulation), primary text
- Krankenhausentgeltgesetz (KHEntgG), Hospital Remuneration Act, § 6 Abs. 2 (NUB charges), primary text
- GKV-Beitragssatzstabilisierungsgesetz, BGBl. 2026 I No. 228, Article 1 No. 56c (new version of Section 137h(1) SGB V; letter d double letter cc: Section 137h(4) sentence 5, NUB charge after a finding of potential only for university hospitals and hospitals meeting the G-BA quality requirements): https://www.recht.bund.de/eli/bund/bgbl-1/2026/228
- G-BA, procedural resolution of 17 September 2026 on the amendment of Section 137h SGB V by the BStabG: https://www.g-ba.de/beschluesse/8019/
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Related insights
All insights →Regulations & standards considered
- Fünftes Buch Sozialgesetzbuch (SGB V), German Social Code, Book V
- § 35a SGB V (early benefit assessment of medicinal products)
- § 130b SGB V (agreement on the reimbursement amount)
- § 137h SGB V (assessment of new diagnostic and treatment methods involving high-risk-class medical devices)
- Arzneimittel-Nutzenbewertungsverordnung (AM-NutzenV), Medicinal Products Benefit Assessment Ordinance
- Regulation (EU) 2021/2282 (EU HTA Regulation)
- Krankenhausentgeltgesetz (KHEntgG), Hospital Remuneration Act, § 6 Abs. 2 (NUB charges)
Related topics
HTA Dossier →
The benefit dossier for the early benefit assessment under § 35a SGB V
Market Access Strategy →
Reimbursement and price planning from the early development phase onward
Tender & Negotiation →
Rebate contracts and hospital tenders following the pricing stage
HEOR & Modeling →
Health-economic models as the basis for the pricing argument
Stakeholder Management & Negotiation →
Negotiation using the Harvard Concept and ongoing stakeholder management
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